Gilead Sciences Receives FDA Warning Letter
On September 21, 2010, Gilead Sciences (San Dimas, CA) received a warning letter from the US Food and Drug Administration, citing violations of current good manufacturing practices (cGMP) for its manufacturing and quality processes related to the production of antifungal agent AmBisome at its California facility.
On September 21, 2010, Gilead Sciences (San Dimas, CA) received a warning letter from the US Food and Drug Administration, citing violations of current good manufacturing practices (cGMP) for its manufacturing and quality processes related to the production of antifungal agent AmBisome at its California facility.
The key deviation cited was that the company failed to maintain defined areas or control systems that are necessary to prevent contamination or mixups during aseptic processing. Also, the company’s environmental monitoring program was not adequate in the aseptic filling areas and the practice used to assess unidirectional airflow in the critical product path was inadequate to prevent product contamination.
Other deviations cited in the warning letter were related to inappropriate written procedures for production and process controls designed to ensure the drug product’s identity, strength, quality, and purity. The letter also said that the company had not cleaned and maintained equipment at appropriate intervals to prevent contamination.
FDA inspectors visited the plant early in the year, and Gilead responded to those concerns on March 2, 2010. The warning letter said that the response lacked sufficient corrective actions. Gilead Sciences now has 15 days to respond to the warning letter.
FDA warning letter
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm227649.htm
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Kyron.bio Raises €5.5M to Advance Precision Glycan Engineering for Safer Antibody Therapeutics
May 28th 2025Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.
